The Efficacy of Probiotic Compared With Placebo Commitment Therapy for Treatment of Major Depressive Disorder

NCT05315401 | Withdrawn Phase 2

• 1 other identifier: JEP-2021-606
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of oral administration of probiotic at 9 log CFU/day as adjunctive treatment in reducing the severity of depression in female patients with major depressive disorder with treatment-as-usual compared to placebo and ACT via the use of questionnaires.

Conditions

Major Depressive Disorder

Keywords

Probiotics

Outcome Measures

Primary Outcomes (1)

• differences in severity of depression in patients with major depressive disorder upon consumption of probiotic at 9 log CFU/day compared to placebo and ACT.

  To evaluate differences in severity of depression via the use of the Montgomery and Åsberg (MADRS) Depression Rating Scale questionnaire containing 10-items on a 7-point scale with higher scores indicating more severe depression

  24 weeks

Secondary Outcomes (3)

• differences in quality of life in patients with major depressive disorder upon consumption of probiotic at 9 log CFU/day compared to placebo and ACT.

  24 weeks

• differences in blood depression biomarkers in patients with major depressive disorder upon consumption of probiotic at 9 log CFU/day compared to placebo and ACT.

  24 weeks

• differences in gut microbiota profiles of patients with major depressive disorder upon consumption of probiotic at 9 log CFU/day compared to placebo and ACT.

  24 weeks

Study Arms (3)

Probiotic 9 log CFU/day

EXPERIMENTAL

The intervention consists of daily administration of one sachet/day of probiotic for 12 weeks, where each sachet contains 9 log CFU of probiotic.

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

placebo contains primarily carrier and without probiotic. The placebo are identical in taste and appearance and appear as a light-yellow powder.

Dietary Supplement: Placebo

Acceptance and commitment therapy (ACT)

EXPERIMENTAL

Patients will be provided with ACT for 12 weeks with treatment as usual. The ACT intervention will be conducted in a group of 10 for each session. The ACT modules covered over 12 sessions, 1 hour in each session. The sessions will be held every week

Behavioral: Acceptance and commitment therapy (ACT)

Interventions

Probiotic DIETARY_SUPPLEMENT

This project aims to evaluate the efficacy of oral administration of probiotic at 9 log CFU/day as adjunctive treatment in reducing the severity depression in female patients with major depressive disorder with treatment-as-usual compared to placebo and ACT via use of questionnaires.

Probiotic 9 log CFU/day

Placebo DIETARY_SUPPLEMENT

This project aims to evaluate the efficacy of oral administration of probiotic at 9 log CFU/day as adjunctive treatment in reducing the severity depression in female patients with major depressive disorder with treatment-as-usual compared to placebo and ACT via use of questionnaires.

Placebo

Acceptance and commitment therapy (ACT) BEHAVIORAL

Patients will be provided with ACT for 12 weeks with treatment as usual. The ACT intervention will be conducted in a group of 10 for each session. The ACT modules covered over 12 sessions, 1 hour in each session. The sessions will be held every week.

Acceptance and commitment therapy (ACT)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female patient diagnosed with major depressive disorder (confirmed by DSM-5 for depression). There is a strong gender predisposition in depression and anxiety disorders, in which females are more prone to have depressive disorders and anxiety disorders than males. Hence, we will only recruit female patients in this study to control for confounding bias.
• Those with score of more than 8 based on Hamilton Depression Rating Scale (HAMD), indicative of mild to moderate severity of depressive symptoms.
• Age 18 to 35 years old

You may not qualify if:

• Pregnant women
• Those who have current and lifetime history of engaging in any psychotherapy
• Those who consumed alcohol and illicit drugs (Heavy or mild)
• Those who has current and lifetime history of other psychiatric illnesses, such as other depressive disorders (persistent depressive disorder, premenstrual dysphoric disorder), anxiety disorders (panic disorder, agoraphobia, generalized anxiety disorder, specific anxiety disorder, and social anxiety disorder), psychotic disorders (schizophrenia, schizophreniform disorder, schizoaffective disorders, brief psychotic disorder, and delusional disorder), bipolar mood disorder, obsessive compulsive disorder, posttraumatic stress disorder, and attention deficit hyperactive disorder, and autism spectrum disorder
• Those who are on medications that can induce psychiatric symptoms, such as cardiovascular agents (clonidine, guanethidine, methyldopa, reserpine, beta blockers), dermatologic agents (isotretinoin), anticonvulsants (levetiracetam), antimigraine medications (triptans), hormonal agents (corticosteroids, oral contraceptives, gonadotropin-releasing hormone agonists, tamoxifen), varenicline, immunological agents (interferons), and levodopa
• Severe gastritis with regular intake omeprazole medication (proton pump inhibitors)
• Women on regular steroid treatment
• Those on long term medication for any illnesses (≥ 6 months)
• Those who are currently on antibiotics or with history of taking antibiotic for the past 2 weeks.
• Those with abnormal full blood count, renal profile, liver function test, fasting blood glucose, fasting lipid profile and ESR (blood collection for all these blood investigations will be carried out in the pre-intervention assessment).
• Patient who has suicidal tendency

Sponsors & Collaborators

• Min-Tze LIONG: lead
• National University of Malaysia: collaborator

Study Sites (1)

Hospital Canselor Tuanku Muhriz UKM Medical Centre

Cheras, Kuala Lumpur, 56000, Malaysia

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Probiotics; Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Min Tze Liong, Prof.Dr

  School of Industrial Technology, University of Science Malaysia

  STUDY DIRECTOR

• Luke Woon Sy-Cherng, Dr

  Department of Psychiatry Hospital Canselor Tuanku Muhriz UKM medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: . The randomization will be performed by the study statistician, who had no contact with the patients and not involve in the research project. The allocation sequence will not be available to any member of the research team until databases had been completed and locked. Since this is a double-blinded study, both the research team and subject will not know in which group the subject is assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor.Dr

Model Details: A double-blind three-armed randomized controlled trial design has been chosen. Randomization for the parallel prevention phase will be carried out after checking the inclusion and exclusion criteria

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 7, 2022
• Study Start: October 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)